Process Approach

Process Approach 

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Para 0.3.1 of ISO 9001:2026 QMS standard states that an organization should run its quality management system as a set of linked processes, not as isolated departments. The purpose is to meet customer requirements and to improve customer satisfaction. The necessary requirements for doing this are mentioned in clause 4.4 of the standard.

In plain language, we can say a process is not a department, it is a set of activities that turns inputs into outputs. The output of one process is often the input to the next. If an organization only manages “Purchasing” and “Production” as separate functions, problems hide at the handoff. The process approach manages those connections.

The standard adds four ideas -

1. Identify processes and manage their interactions so planned results match the quality policy and strategy.  

2. Run the whole system together using the PDCA cycle (Plan–Do–Check–Act).  

3. Use risk-based thinking to prevent unwanted results.  

4. Use opportunity-based thinking (stated more clearly in the 2026 edition) to pursue useful results.

Applied well, this gives consistent fulfilment of requirements, a view of each process in terms of value, risk and opportunity, effective process performance, and improvement based on data.

Figure 1 provided in ISO 9001:2026 standard is the picture mentioning sources of inputs, inputs, activities, outputs, receivers of outputs, and monitoring check points chosen for that process and its risks. (Readers are requested to refer to this figure in ISO 9001:2026 standard.) 

We provide you two linked examples.

Example 1 — Production / manufacturing

Production is not just a machine line. Its sources are purchasing, design and the customer order. Inputs are materials, drawings and energy. Activities are setup, manufacture and packing. Outputs are finished product and records, received by the warehouse or the customer.

The check points match this process’s risks:

1. Incoming / receiving inspection — Stop wrong material entering the line.  

2. In-process checks — Catch setup or parameter drift early.  

3. Final inspection / test — Stop nonconforming product reaching the customer.

That is process approach in practice: process + controls + risk. Purchasing’s output becomes production’s input — the two processes are one system.

Example 2 — Purchasing 

Purchasing is not just raising a purchase order. Its sources are a production requisition, design specifications and the approved-supplier list. Activities are selecting the provider, issuing the order and receiving the item. Outputs are purchased product and certificates, received by the warehouse and production.

The check points are different because the risks are different:

1. Evaluation / re-evaluation of the provider — Avoid an unsuitable supplier.  

2. Review of purchasing information / contract — Avoid a wrong specification on the order.  

3. Verification of what was received — Stop nonconforming product entering production.

A low-risk catalogue item from a proven supplier may need only a document and quantity check. A safety-critical custom part may need source inspection plus incoming dimensional and material checks. That is the rule: check points vary with the process steps and the related risks.

Ten questions to ask when designing and reviewing a process 

A process should not only be defined; it should also be periodically reviewed to determine whether it remains suitable, adequate and effective. The following questions can help an organization when designing a new process or reviewing an existing process: 

(1) What is the purpose of the process?

(2) What are the inputs and intended outputs of the process? 

(3) Who provides the inputs and who receives the outputs?

(4) What activities and sequence are required to achieve the intended outputs?

(5) What resources, knowledge and infrastructure are required?

(6) What are the risks and opportunities associated with the process?

(7) What controls are needed to address the identified risks and opportunities?

(8) How will the performance and effectiveness of the process be monitored and measured?

(9) How does the process interact with other processes within the QMS?

(10) What changes or improvements are needed to achieve better results?

These questions help ensure that a process is designed, controlled, monitored and continually improved to achieve its intended results and contribute to the effectiveness of the QMS. 

In short, process approach requires to manage work as a chain of processes; the above two diagrams show that chain — purchasing feeds production — and put controls where each process’s risk actually sits.

Regards,

Keshav Ram Singhal